Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2026-02-20

Brief Summary

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The goal of this study is to verify the effect of vitamin D3 combined with extensor muscle strengthening exercise in lateral epicondylitis of elbow Are there significant differences in the improvement of functional scores between the study and control groups? Are there significant differences in the improvement of sonographic findings and blood D3 levels between the study and control groups? Participant will underwent D3 injection or saline injection and extensor muscle strengthening exercise with counter force brace. All the participant will undergo functional scoring, sonographic examination and blood D3 level testings until 6 months after initial visit.

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Detailed Description

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Conditions

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Lateral Epicondylitis of Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study group: Vitamin D3 injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counterforce brace for lateral epicondylitis of elbow Control group: Saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counterforce brace for lateral epicondylitis of elbow

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

An independent nurse uses a random sequence generator and allocates the participants into the two groups. Participant, investigator and outcomes assessor were blinded of participants' information

Study Groups

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Vitamin D3 injection

1.0mL Vitamin D3 injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow

Group Type EXPERIMENTAL

Vitamin D3 or Saline injection at ipsilateral deltoid muscle

Intervention Type DRUG

study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection

Saline injection

1.0mL saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow

Group Type PLACEBO_COMPARATOR

Vitamin D3 or Saline injection at ipsilateral deltoid muscle

Intervention Type DRUG

study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection

Interventions

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Vitamin D3 or Saline injection at ipsilateral deltoid muscle

study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection

Intervention Type DRUG

Other Intervention Names

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extensor muscle strengthening exercise with counterforce brace

Eligibility Criteria

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Inclusion Criteria

* lateral epicondylitis(LE) of elbow symptoms that persisted of increased for more than 3 months in which LE was defined as pain on the lateral side of the elbow and pain at the lateral epicondyle upon direct palpation and during resisted dorsiflexion of the wrist

Exclusion Criteria

* younger than 20 years
* history of ipsilateral elbow surgery
* common extensor tendon tears more than 30% in depth
* inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, etc)
* osteoarthritis with a limitation of range of motion (flexion contracture \>30 degree and further flexion \< 100 degree)
* neurological deficits in the ipsilateral upper limb,and follow-ups less than 24 weeks

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No